Stents for Femoropopliteal Disease:

Transcription

1 1 TheZilverPTX RandomizedTrial ofpaclitaxel Eluting Stents for Femoropopliteal Disease: 24 Month thupdate Mark kw. Burket, MD M.D. Professor of Medicine Director of Vascular Medicine University of Toledo Medical Center Toledo, OH On behalf of the Investigators

2 2 Overview Background Zilver PTX drug eluting stent Trial design Patient demographics/lesions Zilver PTX Randomized Trial 24 month update Safety Effectiveness PrimaryPatency Patency 81.2% Zilver PTX vs. 62.7% BMS

3 3 Zilver PTX Drug Eluting Stent Designed dfor the SFA CE Marked Investigational in the USand Japan Dual therapy stent Mechanical support: Zilver Flex Stent Platform Drug coating: Paclitaxel only No polymer or binder 3 µg/mm 2 dose density Sponsor: Cook Medical PTX Coated Uncoated

4 4 Zilver PTX Randomized Trial Prospective, multinational trial Protocol approved by FDA, PMDA and German regulatory authorities CEC and DSMB oversight, and imaging gcore Lab analyses Key inclusion/exclusion criteria Rutherford classification 2 Reference vessel diameter 4 9 mm Lesion length 14 cm De novo or restenotic lesions (no in stent restenosis) > 50% diameter stenosis One lesion per limb (bilateral treatment allowed)

5 5 Zilver PTX Randomized Trial 12 month event free survival Primary safety endpoint Per patient freedom from death, amputation, target lesion revascularization, or worsening Rutherford score (by 2 classes or to class 5 or 6) 12 month primary patency Primary effectiveness endpoint Per lesion patency by duplex ultrasonography, patent = PSVR < 2.0 (or angiography if available, patent = diameter stenosis < 50%) One lesion per limb, bilateral treatment allowed 5 year ongoing gfollow up 2, 3, 4 and 5 year patency evaluations for all stent patients and a randomly selected subset of patients with acutely successful PTA 3 and 5 year stent radiographs

6 6 Clinical Trial Design * Failed PTA = Acute PTA Failure Due to: 30 %DS (including persistent, flow-limiting dissection) on arteriography -OR- 5 mmhg mean transstenotic pressure gradient Secondary Randomization Primary Randomization *Failed PTA 120 Patients PTA 238 Patients Provisional Provisional Bare Zilver Zilver PTX 59 Patients 61 Patients Enrollment 479 Patients Successful PTA 118 Patients Zilver PTX 241 Patients

7 7 Patient Demographics and Comorbidities PTA Zilver PTX P value Patients Age (years) 68 ± ± Male 64% 66% 0.70 Height (in) 66 ± 4 67 ± Weight (lbs) 179 ± ± Diabetes 42% 49% High cholesterol 70% 76% 0.12 Hypertension 82% 89% 0.02* Past/current smoker 84% 86% 0.70 * Statistically significant

8 8 Baseline Lesion Characteristics PTA Zilver PTX P value Lesions Normal to normal lesion length (mm) 63 ± ± Stenosed lesion length (mm) 1,2 53 ± ± Diameter stenosis (%) 1 78 ± ± Total occlusions 25% 30% 0.20 De novo lesions 94% 95% 0.69 Lesion calcification 1 None 5% 2% 1 Angiographic core lab assessment 1 Angiographic core lab assessment 2 Region with > 20% diameter stenosis *Statistically significant Little 38% 26% Moderate 22% 35% Severe 35% 37% < *

9 Safety Event free Survival 9

10 24 Month Safety Event free Survival % 86.6% (Zilver PTX, 203 Patients) urvival Eve ent-free S 82.6% 77.6% (n = 216 patients) 77.6% (PTA, 216 Patients) p < 0.01 Event free Survival: Freedom from CECadjudicated death, amputation, and target lesion revascularization, i or worsening Rutherford score (by 2 classes or to class 5 or 6) Months

11 11 Low Stent Fracture Rate 546stents implanted 453 Zilver PTX (average of 1.5 stents per patient) 93 Zilver BMS X ray core laboratory analysis of 457 stents at 12 months Four stent fractures No associated adverse events 0.9% stent fracture rate through 12 months (next evaluations at 3 and 5 years)

12 12 Month Effectiveness Primary Patency (PSVR < 2.0): Zilver PTX vs. PTA 12 p < 0.01 p < 0.01 PTA (All) Successful PTA Zilver PTX

13 24 Month Effectiveness Primary Patency (PSVR < 2.0): Zilver PTX vs. PTA % 74.8% (Zilver PTX, 187 Lesions) rimary Pa atency P p = % (Successful PTA 116 Lesions) 57.8% 1 (Successful PTA long term subset, 56 Lesions) 32.4% 2 (All PTA 1 Excludes patients with a clinically unacceptable acute PTA result 241 Lesions) (~ 50% of initial PTA cohort) 2 A randomly selected subset of 56 acutely successful PTA patients assign to long term (> 12 mo) follow-up Months

14 12 Month Paclitaxel Effect Patency (PSVR < 2.0): Provisional Zilver PTX vs. BMS % p < % te atency Rat stimate) Primary P n Meier Es 12 month (Kapla 80% 60% 40% 20% 73.0% 0% Provisional Bare Zilver i Zilver Provisional iptx Bare Zilver Zilver Zilver PTX

15 24 Month Paclitaxel Effect Patency (PSVR < 2.0): Provisional Zilver PTX vs. BMS % 81.2% (Provisional Zilver PTX, n = 56 Lesions) ency Pri imary Pat 73.0% p < % (Provisional Bare Zilver, n = 56Lesions) Provisional 24 month Restenosis Group Rate Reduction Zilver PTX 18.8% Bare Zilver 37.3% 50% Months

16 16 Conclusions 24 month monthresults support sustained safety and effectiveness Primary Zilver PTX significantly better patient safety than PTA (p < 0.01) Primary Zilver PTX patency of 74.8% Provisional Zilver PTX patency (81.2%) significantly higher than provisional BMS patency (62.7%, p < 0.01) PTX coating reduces 24 month restenosis rates by 50%